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Based on the official records currently available to Public Health Trace, no recalls naming Agila Specialties Private Ltd. are currently shown as ongoing. The 1 record below is a historical recall record.
Public Health Trace has 1 recall naming Agila Specialties Private Ltd. as the recalling firm, republished from official FDA and USDA sources.
Recall history - 1 terminated record
Recalls by year
A bar chart of the number of recalls naming this company by year.
FDA RecallTerminatedTerminated: December 3, 2015Historical recordClass II
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.
by Agila Specialties Private Ltd.
Reason
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name Agila Specialties Private Ltd. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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